| | | |   By Elizabeth Cooney | Good morning. I’m Isabella Cueto, the inaugural Sharon Begley-STAT Science Reporting Fellow, filling in for Liz. Enjoy the spring blooms popping up on your street, and encourage an early-career journalist you know to apply for this year’s Begley fellowship. | | | FDA breakthrough device program delivers biggest gains to companies, not patients  (Molly Ferguson for STAT) Five years ago, the FDA launched a program to speed development and review of cutting-edge medical devices in hopes of getting them to patients faster. But a monthslong STAT investigation has found that while the program has delivered big benefits to device makers, its value to patients is still unclear. After granting a designation, the FDA never questions the promise that earned a product breakthrough status: Is it actually more effective than what’s already available? “The number of breakthrough device designations have gone up so much, I think it’s pretty clear that definition has been applied very loosely,” one health policy researcher said. STAT’s Katie Palmer and Mario Aguilar scoured hundreds of press releases, social media posts, and regulatory announcements, and with STAT’s J. Emory Parker built the most comprehensive public database of breakthrough devices to date. STAT+ subscribers can explore the database here. | Many physicians think all tobacco products are equally harmful, study says More than half of doctors believe all tobacco products to be equally bad for patients, and are less likely to recommend e-cigarettes to patients looking to quit smoking, a new JAMA Network Open study finds. A majority (70%) of the 2,058 doctors surveyed said patients had asked them about e-cigarettes, but only about 22% reported ever recommending the product to patients — despite mounting scientific research that suggests e-cigarettes can contribute to higher quit rates than other therapies. Physicians who took a harm-reduction approach or had ever been smokers themselves were significantly more likely to recommend e-cigarettes to patients. When presented with a hypothetical clinical scenario, doctors across all groups were more likely to recommend e-cigarettes for older, heavy smokers with multiple attempts at quitting than younger patients who are light smokers and haven’t tried cessation techniques. | Researchers raise alarm on rise in firearm-related deaths among children The leading cause of death, by far, among children and adolescents is injuries. For a long time, motor vehicle collisions were the deadliest injury in those ages 1-24. But since 2017, gun-related deaths top the list. That spike is attributable to the simultaneous crackdown on motor vehicle manufacturing and traffic safety, and the lax approach to gun safety from policymakers and research funders, researchers write in a NEJM Perspective. The number of firearm-related deaths in children, adolescents, and young adults rose from 6,998 in 2000 to 10,186 in 2020, according to the CDC. “As the progress made in reducing deaths from motor vehicle crashes shows, we don’t have to accept the high rate of firearm-related deaths among U.S. children and adolescents. Preventable deaths among young people not only are associated with tremendous medical costs, but take a great personal toll on families and communities,” the researchers write. | Five key considerations to ensure clinical trials better reflect targeted populations The goal of clinical trials is to ensure products are effective and safe for the targeted patients. One important way to advance the mission is to make sure clinical trials more closely reflect the populations intended for treatment. Digital advances are making it easier to expand clinical trial candidate bases to reflect the real-world patient population more accurately. Learn how assessing and restructuring clinical trial design and processes can achieve better representation of target populations. | Kizzmekia Corbett, Moderna vaccine designer, on her path to science and our path out of Covid The world knows Kizzmekia Corbett as one of the designers of the Moderna Covid-19 vaccine. And in her new job at Harvard’s T.H. Chan School of Public Health, Corbett plans to work on vaccine design to help the world better handle future pandemics. Corbett, a STATUS List honoree, spoke with STAT’s Helen Branswell about how she found her way into science and where she thinks the pandemic is headed. I think a lot of people will look at how quickly vaccines were developed and deployed and conclude that we’re always going to be able to do that. But people worked for years researching how to make coronavirus vaccines.
I completely agree. The amount of work and the amount of blood and sweat and tears that went into the development process and that continues to go into assessing the vaccine on a day-to-day basis just cannot be taken for granted. How did you come to realize that science was something that you wanted to do and that it was an option for you?
In high school, I went to get an internship at the University of North Carolina at Chapel Hill. I was able to work in a lab, do really cool experiments during the summer, but also I was just kind of exposed to this environment that someone from my background just doesn't even know existed. You can read the full interview here. | Closer look: Sex differences should be central to vaccine research, trial participant argues Vaccine trials are run to suss out any serious side effects and figure out what dosage works best for certain patient populations. But those trials often ignore biological differences between men and women, and a growing body of evidence that suggests immune responses to vaccination and infection can differ widely between the sexes, writes journalist and filmmaker Dawn Sinclair Shapiro in a STAT First Opinion. After experiencing an alarmingly high fever while part of Moderna’s Phase 3 Covid vaccine trial, Shapiro dove into the history of sex bias in research, from the Petri dish to human trials. “When I dug deeper into vaccine development, I discovered a familiar tug of war in which new scientific recommendations that account for biological sex disparities continue to clash with established practices and beliefs,” she writes. | Parents are giving supplements to their picky-eater kids, but it skews toward the wealthy It can be difficult — and expensive — to make sure picky eaters have a balanced diet, with enough vitamins, minerals, and fiber. Just 52% of parents in a new C.S. Mott Children’s Hospital national poll said their children ages 1-10 eat a “well-balanced diet overall.” That’s why over half of the 2,000 parents surveyed say they have turned to children’s dietary supplements, including multivitamins, probiotics, and omega-3. Nearly half of parents said that it’s expensive to feed their child a healthy diet. Parents with higher incomes were more likely than those with lower incomes to report regular use of a children’s dietary supplement, and more likely to have discussed the addition with their child’s doctor. | In the third episode of the “Color Code” podcast, host Nicholas St. Fleur takes a look at the groundswell of antiracism work in medicine and medical education, and explores the backlash that these endeavors have received. Listen here. | | | | | What to read around the web today - Is Covid more dangerous than driving? How scientists are parsing Covid risks. New York Times
- FDA investigating Lucky Charms after reports of illness. Associated Press
- A tale of many pandemics: In year three, a matter of status and access. Washington Post
- Some uninsured patients face massive hospital bills from private doctors. WBEZ
- A travel nurse leaves fears of hospital drug tampering across three states. Kaiser Health News
| Thanks for reading! More tomorrow,  | | | | Have a news tip or comment? Email Me | | | | | |
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